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.

• 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
• MDR Report Key: 16637245
• MDR Text Key: 312237824
• Report Number: 2020550-2023-00068
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551347843
• UDI-Public: 4048551347843
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2023,03/29/2023

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other