Lapra-TY KA200Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705036012648), received between Jun 6, 2018 and Oct 29, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND THAT DURING EQUIPMENT CHECKING, THE DEVICE WOULD NOT OPEN AND CLOSE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413154 ↗
• MalfunctionOct 29, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND THAT DURING EQUIPMENT CHECKING, THE DEVICE WOULD NOT OPEN AND CLOSE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413057 ↗
• MalfunctionApr 22, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE DEVICES COULD NOT PERFORM LIGATION, AND THEY WOULD OPEN UP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882945 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) FOR PATIENTS UNDERGOING MINIMALLY INVASIVE PROCEDURES. POST-PROCEDURE BLEEDING HAS BEEN IDENTIFIED AS THE REPORTED COMPLICATION AS PER ICD-10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: 137 PATIENTS HAD POST-PROCEDURE COMPLICATION AFTER THE PROCEDURE WITH USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX ADMISSION WAS DEFINED USING DIAGNOSIS CODES (SEE APPENDIX TABLE 1). POST-PROCEDURE SURGICAL SITE INFECTION HAS BEEN IDENTIFIED AS THE REPORTED COMPLICATION AS PER ICD-10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: 15 PATIENTS HAD POST-PROCEDURE COMPLICATION AFTER THE PROCEDURE WITH USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX ADMISSION WAS DEFINED USING DIAGNOSIS CODES (SEE APPENDIX TABLE 1). POST-PROCEDURE WOUND DISRUPTION HAS BEEN IDENTIFIED AS THE REPORTED COMPLICATION AS PER ICD10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: 12 PATIENTS HAD POST-PROCEDURE COMPLICATION AFTER THE PROCEDURE WITH USE OF THE DEVICE AND BEFORE THE DISCHARGE O

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection; Wound Dehiscence

  MAUDE report 16467865 ↗
• MalfunctionAug 25, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A ROBOT ASSISTED SACROCOLPOPEXY, THE HANDLE DIDN'T RELEASE TO GRAB THE LAPRATY CLIPS. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368821 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING REVIEW OF A JOURNAL ARTICLE, TITLE: PROXIMAL LEAKAGE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY: AN ANALYSIS OF PREOPERATIVE AND OPERATIVE PREDICTORS ON 1738 CONSECUTIVE PROCEDURES. AUTHOR/S: GIOVANNI CESANA, STEFANO CIOFFI, RICCARDO GIORGI, ROBERTA VILLA1, MATTEO UCCELLI, FRANCESCA CICCARESE, GIORGIO CASTELLO, BRUNO SCOTTO AND STEFANO OLMI. CITATION: OBES SURG (2018) 28:627¿635; DOI 10.1007/S11695-017-2907-Z; PUBLISHED ONLINE: 24 AUGUST 2017. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO SEARCH FOR PREDICTIVE FACTORS FOR PROXIMAL LEAKAGE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) IN A LARGE COHORT FROM A SINGLE REFERRAL CENTER. FROM JANUARY 2008 TO OCTOBER 2016, ONE THOUSAND SEVEN HUNDRED AND THIRTY-EIGHT PATIENTS (MEDIAN AGE 41.0 (33.0 TO 49.0) YEARS, MALE N=428, FEMALE N=1310) WHO UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY WERE ANALYZED. LSG WAS PERFORMED USING FOUR TROCARS. THE GREAT CURVATURE WAS DISSECTED AND ISOLATED FROM THE GASTROCOLIC LIGAMENT AND THE SPLENOCOLIC LIGAMENT THROUGH AN ULTRASONIC DEVICE (HARMONIC ACE, ETHICON ENDO-SURGERY INC., CINCINNATI, OHIO) OR A RADIOFREQUENCY SEALER DEVICE (LIGASURE MARYLAND JAW, MEDTRONIC, DUBLIN, IRELAND; OR C

  Patient problems: Abdominal Pain; Abscess; Failure to Anastomose; Fever; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9624975 ↗
• MalfunctionJan 16, 2019Difficult to Open or Close

  IT WAS REPORTED THAT THE JAWS OF THE INSTRUMENT WERE NOT OPENING AND CLOSING. NO PATIENT INVOLVEMENT OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253431 ↗
• InjuryJun 12, 2018Leak/Splash; Device Slipped

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROBOT-ASSISTED TOTAL PROSTATECTOMY, THE PLACED CLIP SLID DURING SUTURING AFTER FIXED ON THE MONOCRYL. THE DEVICE WAS USED ON THE ANASTOMOSED SITE BETWEEN THE URETHRA AND THE BLADDER. THE HOSPITALIZATION WAS PROLONGED SINCE LEAKAGE OCCURRED AND THE CATHETER COULD NOT BE REMOVED. NO BLOOD TRANSFUSION WAS REQUIRED.

  Patient problems: Fever; No Code Available

  MAUDE report 7590905 ↗
• InjuryJun 6, 2018Leak/Splash; Device Slipped

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROBOT-ASSISTED TOTAL PROSTATECTOMY, THE PLACED CLIP SLID DURING SUTURING AFTER FIXED ON THE MONOCRYL. THE DEVICE WAS USED ON THE ANASTOMOSED SITE BETWEEN THE URETHRA AND THE BLADDER. THE HOSPITALIZATION WAS PROLONGED SINCE LEAKAGE OCCURRED. NO BLOOD TRANSFUSION WAS REQUIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7575150 ↗