MAUDE Adverse Event Report: CAREFUSION, INC SLIDE-LOCK ROT ATRAU GRASPER DBL-ACT 5MM-NA; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	88-8333
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr # (b)(4).Lot # c21veo - march, of 2021, b21veo - february of 2021, j19veo - october of 2019 the product was returned, and an evaluation was performed.The root cause of this reported issue was not confirmed.The instruments were manufactured according to the product specification drawing.A visual and physical examination was conducted on each device.Devices passed all inspection criteria and function as intended.Failure mode could not be replicated.A review of dhrs 11039-01, 12338-03, and 12419-06 revealed no non-conformances or deviations.Devices pass all inspection criteria and function as intended.Failure mode could not be replicated.This complaint was escalated to a medical device reportable by the customer, bd.Endoplus will not file a report based on there being no evidence of device malfunction leading to an adverse event causing serious injury 21 cfr 803.3.There was not one specific procedure noted in the complaint nor were there any medical procedures performed on the tissue.All procedures were completed as planned.Because devices passed all inspection criteria and failure mode could not be replicated, no immediate action is necessary.Devices will be returned to customer.
Event or Problem Description
Atraumatic slide lock handle is very difficult to unlock once in the locked position and it is causing the jaw to pull and in some cases tear tissue.There have been instances of torn tissue on a patient due to the jaw pulling too hard when the handle is unable to unlock.This customer recently replaced their slide locks #88-8333 across the board and the surgeons started noticing the difference almost immediately with the new slide-locks.They have had surgeon complaints from 3 of the 5 using this instrument.19jul2021 additional information: what was the procedure that was being performed? multiple procedures.Was there a medical procedure performed due to the torn tissue? there was not.What was the patient¿s outcome? have not had a poor outcome.Was the procedure completed as planned? yes.Can you please send all parts of the instrument for evaluation? yes, if we have the ability to have a backup plan.Do you have the lot number? no.Do you have photos of the reported issue on the instrument? no, sent 3 graspers with sales rep for evaluation.Was the product received in this condition? not sure.How many instruments have this reported issue of difficult to unlock once in the locked position? and are you returning all of them? yes, how many of these instruments with locking issues tore patient tissue? unsure.No further information available.

• Brand Name: SLIDE-LOCK ROT ATRAU GRASPER DBL-ACT 5MM-NA
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 12219616
• Report Number: 1423507-2021-00039
• Device Sequence Number: 4002506
• Product Code: HET
• UDI-Device Identifier: 10885403154461
• UDI-Public: (01)10885403154461
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K925079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2021
• Report Date (Section F): 07/19/2021

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 Model Number: 88-8333
• Device Catalogue Number: 88-8333
• Device Lot Number: C21VEO
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Date Report to Manufacturer: 07/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other