MAUDE Adverse Event Report: MICROLINE SURGICAL RNNEW SUPER ATRAUMATIC GRABBER TIP, DISPOSABLE; RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, SINGLE USE

Model Number	3622
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, microline surgical has reached out to the affected customer to see if the device can be returned for an investigation.If the device is returned and an investigation is done, a final adverse event report will be submitted.
Event or Problem Description
Disposable renew super atraumatic grabber tip broke into two pieces inside the patient's abdomen.The broken grasper caused retraction of bowel to be lost due to inability to grasp.One small piece of grasper fell freely into patient's abdomen.The piece was retrieved by the surgeon with use of laparoscope guidance and new grasper.
Event or Problem Description
The disposable renew super atraumatic grabber tip fractured into two pieces inside the patient's abdomen during the procedure.As a result, the surgeon was unable to maintain retraction of the bowel due to the inability to grasp.A small fragment of the broken grasper fell freely into the abdominal cavity.The surgeon successfully retrieved the loose piece using laparoscopic guidance and a new grasper.
Additional Manufacturer Narrative
Despite requests made to the customer, the specific device associated with this complaint was not returned to microline sugical for a product evaluation, as a result, the resorted issuse could not be confirmed.

• Brand Name: RNNEW SUPER ATRAUMATIC GRABBER TIP, DISPOSABLE
• Common Device Name: RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, SINGLE USE
• Manufacturer (Section D): MICROLINE SURGICAL; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd; beverly, MA 01915 ; 9789229810
• MDR Report Key: 22060238
• Report Number: 1223422-2025-00013
• Device Sequence Number: 15570611
• Product Code: GEI
• UDI-Device Identifier: 00811099010142
• UDI-Public: 00811099010142
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K213127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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 Model Number: 3622
• Device Catalogue Number: 3622`
• Device Lot Number: 00177034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White