MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW LAPCLINCH GRASPER TIP, DISPOSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3252
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This evaluation was conducted solely on the review of documentation and photos provided by the customer.The subject grasper was not returned for physical examination.The customer claims that during surgery the lapclinch grasper when clamped , malfunctioned, breaking the pivot loop, which broke free.Upon examination of the photo(s) it is clearly seen that the loop is broken and a portion of the external loop is missing.The details in the photograph are not defined when enlarged to indicate a failure mode.The loop is subjected to high and concentrated loads when clamping over an object not easily compressed.This complaint was one of four complaints for a similar failure of the pivot loop.A capa (b)(4) was opened to investigate and provide a root cause and corrective action.
Event or Problem Description
It was reported that item number 3252, lap clinch, was being used during a laparoscopic cholecystectomy.When the surgeon went to clamp down on the patient's gall bladder, the lap clinch tip popped, and it was observed that a portion of the hinge of the grasper broke off and fell into the patient abdomen.It was reported that the stray portion was retrieved from the patient.

• Brand Name: RENEW LAPCLINCH GRASPER TIP, DISPOSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 12578149
• Report Number: 1223422-2021-00008
• Device Sequence Number: 7046179
• Product Code: GEI
• UDI-Device Identifier: 00811099010074
• UDI-Public: 00811099010074
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K981389
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2026
• Device Model Number: 3252
• Device Catalogue Number: 3252
• Device Lot Number: 00155188
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1