Kii® OPTICAL ACCESS SYSTEM CTR34Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915124243), received between Aug 2, 2022 and Aug 2, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: LAPAROSCOPIC PROCEDURES. EVENT DESCRIPTION: (B)(4). DATE OF EVENT: (B)(6). THE SURGEON USE THE OPTICAL TECNIC FOR THE FIRT ACCES IN LAPAROSCOPIC PROCEDURES . DURING 2 DIFFERENT PROCEDURES THE OPTURATOR OF THE TROCAR IS TOO SMALL TO HOUSE THE LAPAROSCOPE. THE SURGEON INFORM THAT THE 5 TROCARS HAD THE SAME PROBLEM, BUT SHE DON'T REMEMBER THE MODEL AND THE LOT OF THIS TROCARS. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: MODEL CTR34 LOT 1424056. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: BRAND OF LAPAROSCOPE: [BRAND NAME] MODEL OF THE LAPAROSCOPE: 30° OPTICS SIZE: 10MM ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: THE USER EXPERIENCED INCONSISTENT RESISTANCE DURING INSTRUMENT MANIPULATION. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15153952 ↗
• MalfunctionAug 2, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: LAPAROSCOPIC PROCEDURES EVENT DESCRIPTION: EVENT 1 OF 5: (B)(4) EVENT 2 OF 5: (B)(4), EVENT 3 OF 5: (B)(4), EVENT 4 OF 5: (B)(4), EVENT 5 OF 5: (B)(4). DATE OF EVENT: (B)(6)2022 THE SURGEON USE THE OPTICAL TECNIC FOR THE FIRT ACCES IN LAPAROSCOPIC PROCEDURES . DURING 2 DIFFERENT PROCEDURES THE OPTURATOR OF THE TROCAR IS TOO SMALL TO HOUSE THE LAPAROSCOPE. THE SURGEON INFORM THAT THE 5 TROCARS HAD THE SAME PROBLEM, BUT SHE DON'T REMEMBER THE MODEL AND THE LOT OF THIS TROCARS. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6)2022: MODEL CTR34 LOT 1424056. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6)2022 : BRAND OF LAPAROSCOPE: [BRAND NAME] MODEL OF THE LAPAROSCOPE: 30° OPTICS SIZE: 10MM ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 12JULY22: THE USER EXPERIENCED INCONSISTENT RESISTANCE DURING INSTRUMENT MANIPULATION. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15153941 ↗
• MalfunctionAug 2, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: LAPAROSCOPIC PROCEDURES EVENT DESCRIPTION: (B)(4). DATE OF EVENT: (B)(6) 2022. THE SURGEON USE THE OPTICAL TECNIC FOR THE FIRT ACCES IN LAPAROSCOPIC PROCEDURES . DURING 2 DIFFERENT PROCEDURES THE OPTURATOR OF THE TROCAR IS TOO SMALL TO HOUSE THE LAPAROSCOPE. THE SURGEON INFORM THAT THE 5 TROCARS HAD THE SAME PROBLEM, BUT SHE DON'T REMEMBER THE MODEL AND THE LOT OF THIS TROCARS. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: MODEL CTR34 LOT 1424056. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: BRAND OF LAPAROSCOPE: [BRAND NAME] MODEL OF THE LAPAROSCOPE: 30° OPTICS SIZE: 10MM ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: THE USER EXPERIENCED INCONSISTENT RESISTANCE DURING INSTRUMENT MANIPULATION. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15153939 ↗
• MalfunctionAug 2, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: LAPAROSCOPIC PROCEDURES. EVENT DESCRIPTION: EVENT 1 OF 5: 2022-001526 EVENT. 2 OF 5: 2022-001535. EVENT 3 OF 5: 2022-001536. EVENT 4 OF 5: 2022-001537. EVENT 5 OF 5: 2022-001538. DATE OF EVENT: (B)(6) 2022. THE SURGEON USE THE OPTICAL TECNIC FOR THE FIRST ACCESS IN LAPAROSCOPIC PROCEDURES. DURING 2 DIFFERENT PROCEDURES THE OPTURATOR OF THE TROCAR IS TOO SMALL TO HOUSE THE LAPAROSCOPE. THE SURGEON INFORM THAT THE 5 TROCARS HAD THE SAME PROBLEM, BUT SHE DOESN'T REMEMBER THE MODEL AND THE LOT OF THIS TROCARS. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: MODEL CTR34 LOT 1424056. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: BRAND OF LAPAROSCOPE: [BRAND NAME] MODEL OF THE LAPAROSCOPE: 30° OPTICS SIZE: 10MM. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: THE USER EXPERIENCED INCONSISTENT RESISTANCE DURING INSTRUMENT MANIPULATION. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15153932 ↗
• MalfunctionAug 2, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: LAPAROSCOPIC PROCEDURES: EVENT DESCRIPTION: EVENT 1 OF 5: 2022-001526, EVENT 2 OF 5: 2022-001535, EVENT 3 OF 5: 2022-001536, EVENT 4 OF 5: 2022-001537, EVENT 5 OF 5: 2022-001538. DATE OF EVENT: (B)(6) 2022. THE SURGEON USE THE OPTICAL TECNIC FOR THE FIRT ACCES IN LAPAROSCOPIC PROCEDURES . DURING 2 DIFFERENT PROCEDURES THE OPTURATOR OF THE TROCAR IS TOO SMALL TO HOUSE THE LAPAROSCOPE. THE SURGEON INFORM THAT THE 5 TROCARS HAD THE SAME PROBLEM, BUT SHE DON'T REMEMBER THE MODEL AND THE LOT OF THIS TROCARS. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 15JUNE2022: MODEL: CTR34 LOT: 1424056. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 1JULY2022: BRAND OF LAPAROSCOPE: [BRAND NAME] MODEL OF THE LAPAROSCOPE: 30° OPTICS SIZE: 10MM. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 12JULY2022: THE USER EXPERIENCED INCONSISTENT RESISTANCE DURING INSTRUMENT MANIPULATION. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15153841 ↗