MAUDE Adverse Event Report: OVESCO ENDOSCOPY USA OTSC SYSTEM SET

Catalog Number	100.31
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and therefore not available for technical analysis.The otsc and twin grasper were used for hemostasis treatment when the grasper was accidentally clipped to the tissue.It was reported that before clip deployment the grasper was pulled back but the visability was very limited.It is stated in the instructions of use that the grasping device must be sufficiently be drawn back to the application cap while the clip is released.Otherwise there is a risk that the clip may be applied to the instrument shaft or the branches and the instrument may become attached to the tissue as a result.There is no indication of a product malfunction.
Event or Problem Description
The otsc was used for the treatment of a bleeding in the duodenal bulb.A twin grasper was used for tissue mobilization.The tissue was fibrotic and therefore difficult to mobilize into the cap.The user did not realize that the grasping instrument had not been retracted far enough into the cap.In the following the twin grasper was accidentally clipped to the tissue.The patient was then admitted to the hospital the following day to have the grasping device removed.In the meantime, the grasper had detached itself from the clip and could be removed without any problems.The clip was still firmly in place in the tissue and had sealed the haemorrhage.No further treatment of the patient was necessary.
Additional Manufacturer Narrative
Follow-up report: addition of related report number (0506030000-2025-8001) in field h10.No further content change.

• Brand Name: OTSC SYSTEM SET
• Common Device Name: OTSC SYSTEM SET
• Manufacturer (Section D): OVESCO ENDOSCOPY USA; 15300 weston pkwy, ste 101; cary NC 27513
• Manufacturer (Section G): OVESCO ENDOSCOPY USA; 15300 weston parkway; cary NC 27513
• MDR Report Key: 22607138
• Report Number: 3008720584-2025-00001
• Device Sequence Number: 20179408
• Product Code: PKL
• UDI-Device Identifier: 04260206310334
• UDI-Public: 04260206310334
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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 Catalogue Number: 100.31
• Device Lot Number: 25J017
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• 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: Hospitalization
• Patient Sex: Unknown