MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD TISCHLER - SHAFT ONLY; M7 - OB-GYN

Model Number	30-1495
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that while obtaining a vaginal tissue sample during a well women exam, the clamp/tischler - shaft only (30-1495) would not release and injured the patient.As a result, the patient experienced discomfort and bleeding.The exam was completed without significant delay.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4 (product serial number, udi#), d9, g3, g6, h2, h3, h6, h10.The tischler - shaft only (30-1495) was returned for evaluation.Device history record (dhr): no abnormalities related to the reported issue were identified.Failure analysis: the returned tischler - shaft/clamps were received in used condition with wear and staining across the surface.The handles were difficult to open and close.When the shaft was removed, the handles were able to open and close without issue, indicating issues with the jaws.Root cause: the reported complaint was confirmed.Evaluation noted the tischler - shaft were in used condition with the jaws sticking.This issue may be the result of wear or debris inside the hinge.No manufacturing, workmanship, or material deficiency has been identified.

• Brand Name: TISCHLER - SHAFT ONLY
• Common Device Name: M7 - OB-GYN
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15396922
• Report Number: 3014334038-2022-00197
• Device Sequence Number: 5007081
• Product Code: HFB
• UDI-Device Identifier: 10381780428206
• UDI-Public: 10381780428206
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 30-1495
• Device Catalogue Number: 30-1495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 10/06/2022; 11/12/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/11/2022; 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female