MAUDE Adverse Event Report: AESCULAP AG DORSEY GRASPING FORCEPS 3.5MM 290MM; LAPAROSCOPIC SURGERY

Model Number PO305R

Device Problem Compatibility Problem (2960)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/25/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with dorsey grasping forceps.It was reported that the product was taken out of the washer after manual cleaning after the surgery, the tip of the jaw insert was found detached.According to surgeons, there was no problem with the complaint product during manual cleaning, but just in case a ct scan was conducted to check if other parts remained in the patient's body.Nothing came out.All the parts were retrieved from the washer basket.Surgeons are worried that parts can easily fall apart.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results after receipt of the device: the jaw parts are detached from the instrument and dhe gripping surfaces of the moveable jaws are damaged, most likely caused during application or reprocessing.Furthermore the proximal end of one of the moveable jaw parts is bent, most likely caused by torsion or leverage during handling.The traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.The failure is most probably caused due to insufficient usage.The breakage of the pin, and therefore the loosening of the moveable jaw parts, was most likely caused by an overload situation during handling or reprocessing.

• Brand Name: DORSEY GRASPING FORCEPS 3.5MM 290MM
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10416021
• MDR Text Key: 203651273
• Report Number: 9610612-2020-00388
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K940936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PO305R
• Device Catalogue Number: PO305R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention