MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE; HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)

Model Number A4829

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during an unspecified surgical procedure the joint at the distal end of the grasping forceps broke and a fragment fell into the patient.However, no fragments remained inside the patient since they were reportedly retrieved.No further information was provided but the intended procedure was completed successfully and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus china sales and marketing service center, china (returned to ocsm on 2020-10-27).The evaluation at the service center confirmed that the distal end of the grasping forceps is severely damaged.The pin at the joint of the grasping section is missing and the instrument shows distinct signs of wear and tear as well as corrosion.The cause of this damage is most likely excessive force in combination with incorrect reprocessing.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the grasping forceps without showing any abnormalities.The case will be closed on olympus side and the user will be informed about the investigation results.

• Brand Name: GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE
• Type of Device: HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10747013
• MDR Text Key: 224685734
• Report Number: 9610773-2020-00248
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A4829
• Device Catalogue Number: A4829
• Device Lot Number: 202W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1