MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, CURVED; NEEDLE HOLDERS (HANDLES, JAWS INSERTS)

Model Number WA64710A

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

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

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to the manufacturer 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 therapeutic laparoscopic procedure, the jaws of the needle holder broke apart and fell inside the patient's body cavity while the operating surgeon was suturing.However, no fragment remained inside the patient since it was reportedly retrieved.The intended procedure was successfully completed with a similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was returned to the manufacturer for investigation.The investigation confirmed that the stationary jaw of the grasping forceps had broken off.In the last months, an increased occurrence of complaints regarding this phenomenon was noticed and, thus, a capa was initiated (refererence #capa (b)(4)).In addition, a sales stop was implemented as part of this capa.In the course of the capa investigation, the following two contributing factors were identified as the root cause: 1.Undersized cross-section due to construction specifications and minor deviations that may occur during the manual production processes, and 2.Metallurgical embrittlement caused by the influences of the heat treatment during the manual soldering process.Thus, the root cause of the breakage was identified as a design weakness that may lead to the reported phenomenon if both factors occur at the same time in a worst case scenario.Suitable countermeasures as well as risk and trending evaluations are performed within the capa process.The risk to patient, user, and/or third party associated with this phenomenon was evaluated as acceptable.This case will be closed from olympus side since all further activities will be covered by the capa.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, CURVED
• Type of Device: NEEDLE HOLDERS (HANDLES, JAWS INSERTS)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7129671
• MDR Text Key: 96021725
• Report Number: 9610773-2017-00136
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: PK923982
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA64710A
• Device Catalogue Number: WA64710A
• Device Lot Number: 172W
• Other Device ID Number: 04042761031073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HANDLE "HIQ+", INLINE A, ASYMMETRIC (WA60120A)