MAUDE Adverse Event Report: CAREFUSION, INC GRASPER, ATRAUMATIC, 37CM, MODULAR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	88-8335
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) - the sample was provided, and an evaluation was performed.The root cause is overstressing of the instrument.The product would have been manufactured and tested according to the specifications.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.
Event or Problem Description
Material no: 88-8335, batch no: b23veo.It was reported by the customer that pin broke from jaw during case while inside patient.Verbatim: pin broke from jaw during case inside patient.Pin was not recovered and hospital is recommending the patient get x-ray to confirm possible product retention.Additional information received 09-may-2023 what is the lot number? b23veo.What was the procedure that was being performed? laparoscopic appendectomy.Was there any attempt to retrieve the part that fell into the patient¿s body and how? not to my knowledge.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? yes.X-ray.What was the patient¿s outcome? i am not privileged to patient information.Was the procedure completed as planned? yes.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.I am not privileged to patient information.Please describe any additional, unplanned medical or surgical intervention (e.G., additional/alternative medications, imaging, etc.) required to avoid patient harm, if not previously provided.N/a.Please provide any available patient information including: age/ date of birth, sex, weight, ethnicity, race, other relevant history including preexisting medical conditions.I am not privileged to patient information.

• Brand Name: GRASPER, ATRAUMATIC, 37CM, MODULAR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 16966470
• Report Number: 1423507-2023-00091
• Device Sequence Number: 5491891
• Product Code: GEI
• UDI-Device Identifier: 10885403219924
• UDI-Public: (01)10885403219924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2023
• Report Date (Section F): 05/18/2023

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 Model Number: 88-8335
• Device Catalogue Number: 88-8335
• Device Lot Number: B23VEO
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/18/2023