MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM 1 S 3D LAP, 30°; RIGID VIDEO LAPAROSCOPE

Model Number 26605BA

Device Problem Use of Device Problem (1670)

Patient Problem Bowel Burn (1756)

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

According to the complaint description the event occurred during robotic rectopexy procedure.During retraction of the bowel, it was largely touching the endoscope shaft for a longer period of the procedure, which resulted in a burning track on the bowel.The endoscope was hot and impacted the tissue.The bowel was over sutured on the specific places of burns.There were some serosa burns present on the bowel.The procedure was converted to laparoscopic for additional suturing and double-checking bowel.The procedure was extended 30 minutes or more due to the problem.

Manufacturer Narrative

The device was not returned to the manufacturer and was therefore not available for investigation.According to the reporter, the incident occurred during a robotic-assisted rectopexy procedure.While the bowel was being retracted, it touched the endoscope shaft for an extended period, resulting in a burn (burns to the serosa) to the bowel.The bowel was sutured closed at the appropriate burn sites.Due to the high light intensity, tissue contact with the distal light exit aperture should be avoided and a sufficient distance from the surrounding tissue should be maintained.The light output must be selected accordingly.The procedure was changed to laparoscopic for additional suturing of the bowel at the burn sites.The procedure was prolonged by 30 minutes or more due to the problem.We exclude a production/manufacturing error on the part of the optics according to the information available to us.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TIPCAM 1 S 3D LAP, 30°
• Type of Device: RIGID VIDEO LAPAROSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA
• MDR Report Key: 16637246
• MDR Text Key: 312233693
• Report Number: 9610617-2023-00068
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551347843
• UDI-Public: 4048551347843
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K150525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26605BA
• Device Catalogue Number: 26605BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other