Zoom coupler Arthrex 14-29mm C-Mount E240Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056702002268), received between May 15, 2019 and Jun 20, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Image Orientation Incorrect” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2022Image Orientation Incorrect

  ON 05/31/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT (2) AR-3210-0006 COUPLERS ARE EXPERIENCING AN ISSUE WITH ZOOMING, AND AUTO FOCUSING. THE IMAGE IS NOT CENTERED ON THE TOWER. THIS OCCURRED ON (B)(6) 2022 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CASE HAD TO BE ABORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 06/07/2022: THE PATIENT WAS SEDATED WITH TRANSABDOMINAL PREPERITONEAL BLOCK (TAPP). THERE WAS NO SKIN INCISION MADE, AN THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744812 ↗
• MalfunctionJun 20, 2022Image Orientation Incorrect

  ON 05/31/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT (2) AR-3210-0006 COUPLERS ARE EXPERIENCING AN ISSUE WITH ZOOMING, AND AUTO FOCUSING. THE IMAGE IS NOT CENTERED ON THE TOWER. THIS OCCURRED ON (B)(6) 2022 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CASE HAD TO BE ABORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 06/07/2022: THE PATIENT WAS SEDATED WITH TRANSABDOMINAL PREPERITONEAL BLOCK (TAPP). THERE WAS NO SKIN INCISION MADE, AN THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744798 ↗
• MalfunctionAug 18, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DIAGNOSTIC LAPAROSCOPY PROCEDURE, THE PATIENT GOT BURNED. THE BURN WAS DISCOVERED BY THE PATIENT AFTER THE SURGERY. THE FOLLOWING DEVICES WERE USED DURING THE PROCEDURE: SS9-GYW50W108 / BATCH WO155094, AR-3210-0030, S/N (B)(4), AR-3210-0006, S/N (B)(4), AR-3351-5500, S/N (B)(4). NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Burn, Thermal

  MAUDE report 10422385 ↗
• InjuryMay 15, 2019Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT UPON INSPECTION OF THE C-MOUNT ZOOM COUPLER, AR-3210-0006, IT HAD CLEAR VISIBLE DAMAGE AND THE COUPLER DID NOT SCREW INTO THE SCOPE PROPERLY. THE BROKEN COUPLER WAS TAGGED FOR ISOLATION AND, IN THIS INSTANCE, IT WAS NOT USED. UNFORTUNATELY IT WAS PUT BACK INTO SERVICE AND THE NEXT SURGEON OPERATED USING THE DAMAGED COUPLER. DURING A CYSTOSCOPY PROCEDURE, THE C-MOUNT ZOOM COUPLER, AR-3210-0006, WAS USED AND PIERCED THE PATIENT'S BLADDER WALL LEADING TO AN OVERNIGHT STAY IN THE HOSPITAL TO MONITOR PATIENTS CONDITION. NO FURTHER DETAILS PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 5/1/2019: THE ZOOM OPTICAL C-MOUNT COUPLER WAS NOT ABLE TO SCREW IN PROPERLY TO THE C-MOUNT CAMERA. DURING THE OPERATION THE COUPLER DISENGAGED FROM THE CAMERA AND THE SCOPE INADVERTENTLY PIERCED THE PATIENTS BLADDER WALL. THE SCOPE USED WAS NOT AN ARTHREX SCOPE. AT THIS STAGE THE PRIMARY OBJECTIVE OF THE CYSTOSCOPY WAS ALREADY COMPLETED AND THE SURGEON WAS HAPPY TO END THE CASE. THE PATIENT WAS ADMITTED OVERNIGHT POST SURGERY FOR OBSERVATION PURPOSES. NO SUBSEQUENT ISSUES WERE REPORTED AND THEY WHERE ALLOWED TO GO HOME THE FOLLOWING MORNING.

  Patient problems: Injury

  MAUDE report 8611494 ↗