MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE; HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)

Model Number A4825

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

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 11/23/2020

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 a therapeutic hysteroscopy procedure, it was noticed that the tip at the distal end of the grasping forceps had broken off and was missing.It is assumed that the fragment may have fallen into the patient.The missing fragment could not be located however.The instrument had reportedly been examined before the procedure and found to be in good working order.The patient was informed about the incident but there are currently no reports about an adverse event or patient injury.

Manufacturer Narrative

Corrected data: h6 - health effect - clinical code.Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that one jaw at the distal end of the grasping forceps is broken off.There are signs of corrosion at the distal end of the grasping forceps and the whole instrument including the handle shows distinct signs of wear and tear.Furthermore, the item is bent multiple times.The damage found was very likely caused by improper handling, use-related wear an tear, possibly in combination with inadequate reprocessing.Therefore, this event/incident was attributed to use error.Also, 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 with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: GRASPING FORCEPS, SHARK TEETH, 5 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: 11163183
• MDR Text Key: 244098607
• Report Number: 9610773-2021-00044
• Device Sequence Number: 1
• Product Code: NWW
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A4825
• Device Catalogue Number: A4825
• Device Lot Number: 164W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1