MAUDE Adverse Event Report: INTEGRA YORK, PA INC. SLIDE LOCK TENACULUM FORCEPS 5MM 32CM; NONE

Catalog Number 605152

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

Customer initially reports that the single tooth tenaculum forcep tips noticed to be limping downwards in the peritoneum after being used for a while.Upon inspection, it was noticed that a piece might have broken off from the working element of the articulating joint.A black small speck of metal was found on top of the uterus and was removed.It appeared that a screw or pin that holds the tips together might have fallen off or broke intraoperatively.On (b)(6) 2015 customer replays that a laparoscopic abdominal - hysterectomy, bilateral salpingectomy and cysto was being performed.X-ray was taken prior to wound closure.It was read negative but the positioning exposure was suboptimal.No intraoperative harm done.A black speck was retrieved but the completeness of the missing part was undetermined.

Manufacturer Narrative

On (b)(6) 2015 integra investigation completed.Failure analysis, device history eval.Failure analysis - a forcep in used condition, showing a purple tape marking, was returned.Upon the eval of the instrument it was noticed that the screw at the jaw area is not attached/fallen off, causing the jaw to hang.It is also noticed that the insulation is damaged and there is staining.Device history/eval- nonconforming product report/ nonconforming material report history: none.Variance authorization/ deviation history: none.Engineering change order/mfg change order history: there is no applicable- engineering change order/mfg change order history.Corrective action preventive action history: none.Health hazard eval history: none.Conclusion: the complaint report has been confirmed; the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: SLIDE LOCK TENACULUM FORCEPS 5MM 32CM
• Type of Device: NONE
• Manufacturer (Section D): INTEGRA YORK, PA INC.; york PA 17402
• Manufacturer Contact: sandra lee ; 315 enterprise dr.; plainsboro, NJ 08536 ; 6099366828
• MDR Report Key: 4850014
• MDR Text Key: 5871629
• Report Number: 2523190-2015-00033
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 605152
• Device Lot Number: 1141468
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 43 YR