MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MACRO FORCEPS 5/420MM ENDOSCOPY

Model Number PM436R

Device Problem Overheating of Device (1437)

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

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhz-5000 digital microscope and a panasonic dmc tz8 digital camera. We made a visual inspection of the instrument. Here we found a bent pull rod pm434203. Furthermore we made a visual inspection of the jaw parts. Here we found a not laterally overlapping jaw. Additionally we found a visibly damaged grey ceramic with a broken off area and a broken grey ceramic. Conclusion and root cause: the root cause of the problem is most probably usage related. Rational: we assume a mechanical overload situation as the causal factor and these will result in the not overlapping jaw and ceramic breakages. There is the possibility of torsion or high leverage with the instrument. According to the quality standard a production error and a material defect can be excluded. No capa is necessary.

Manufacturer Narrative

(b)(4). Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: usa. The surgeon reported that during use the tip of the insert jaw over heats during surgery. No harm to patient reported. No surgical delays reported.

• Brand Name: JAW INS.BIP.MACRO FORCEPS 5/420MM
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6653630
• MDR Text Key: 246681509
• Report Number: 9610612-2017-00327
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PM436R
• Device Catalogue Number: PM436R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 06/07/2017
• Event Location: No Information
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/20/2017 Patient Sequence Number: 1