MAUDE Adverse Event Report: OVESCO ENDOCOPY AG OTSC; OTSC SYSTEM SET

Model Number	100.10
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Misassembly by Users (3133)
Health Effect - Clinical Codes	Peritonitis (2252); Bowel Perforation (2668)
Date of Event	04/08/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
According to the information available, the otsc was not mounted on the endoscope all the way to the stoppers inside the cap.This results in a deeper cap space, which can promote the entrapment of external tissue structures.The unintentional injury of neighbouring tissue structures is a rare, yet known risk and assessed in the risk management file.Furthermore, the evaluation of the production related quality records revealed no abnormalities that indicate a product defect or a production related error.The assessment of the prrc revealed, that the root cause of the error is a procedural complication.
Event or Problem Description
It was reported that after colorectal polyp removal, the removal site was closed with an otsc clip in a extra tight manner as a precaution against possible bleeding due to dual anticoagulation of the patient.Due to incomplete advancement of the endoscope tip into the otsc cap upon device installation, a larger space inside the cap resulted.When aspirating the rectal target tissue into the cap adjacent jejunal tissue was inadvertently entrapped and clipped.This led to secondary perforation of the bowel loop a few days after and resulted in peritonitis.The patient had to be treated surgically.Due to the patient's advanced underlying malignant disease, he did not recover under postoperative care and died a few days later.
Event or Problem Description
It was reported that after colorectal polyp removal, the removal site was closed with an otsc clip in a extra tight manner as a precaution against possible bleeding due to dual anticoagulation of the patient.Due to incomplete advancement of the endoscope tip into the otsc cap upon device installation, a larger space inside the cap resulted.When aspirating the rectal target tissue into the cap adjacent jejunal tissue was inadvertently entrapped and clipped.This led to secondary perforation of the bowel loop a few days after and resulted in peritonitis.The patient had to be treated surgically.Due to the patient's advanced underlying malignant disease, he did not recover under postoperative care and died a few days later.
Additional Manufacturer Narrative
According to the information available, the otsc was not mounted on the endoscope all the way to the stoppers inside the cap.This results in a deeper cap space, which can promote the entrapment of external tissue structures.The unintentional injury of neighbouring tissue structures is a rare, yet known risk and assessed in the risk management file.Furthermore, the evaluation of the production related quality records revealed no abnormalities that indicate a product defect or a production related error.The assessment of the prrc revealed, that the root cause of the error is a procedural complication.

• Brand Name: OTSC
• Common Device Name: OTSC SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOCOPY AG; friedrich-miescher-strasse 9; tübingen, 72076 ; GM 72076
• Manufacturer (Section G): OVESCO ENDOCOPY AG; friedrich-miescher-strasse 9; tübingen, baden württemberg 72076 ; GM 72076
• MDR Report Key: 19307312
• Report Number: 3006696607-2024-00005
• Device Sequence Number: 15100536
• Product Code: PKL
• UDI-Device Identifier: 04260206310082
• UDI-Public: 4260206310082
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: 100.10
• Device Catalogue Number: 100.10
• Device Lot Number: 849630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2024
• Supplement Date Received by Manufacturer: 04/28/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 85 KG