MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS.

Model Number LP-10-120

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc. Is currently investigation the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. Ref: (b)(4). Update: investigation, review dhr, inspect returned samples. Analysis and findings: a review of the 2 yr complaint history reveals no similar issues. A review of the dhr reveals no anomalies. Service & repair did not find anything out of order during a visual inspection of the board. No cold solders were apparent, no missing components, and no damage was noted. The unit passed hi-pot testing as well. The unit works fine. The complaint is not confirmed. The pad used and returned is not dual and not a cooper recommended pad. Error on the part of end user is likely. The doctor may have produced an alternative path to ground. This cold have occurred by leaning on a patient's skin. Correction and/or corrective action: the unit was converted into a demo unit. The customer received a new unit. This complaint will be entered into the coopersurgical continuous improvement plan (cip). Reason: no applicable correction available to train to at this time. Complaints will be continuously monitored to determine if there is any new trend for this complaint condition. Was the complaint confirmed? no.

Event Description

(b)(4). "dr. (b)(6) pressed the cut button on the hand piece and got shocked twice. ".

Manufacturer Narrative

Coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. (b)(4).

Event Description

(b)(4). "dr. (b)(6) pressed the cut button on the hand piece and got shocked twice. ".

• Brand Name: LEEP PRECISION INTG. SYS.
• Type of Device: LEEP
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6690738
• MDR Text Key: 247160158
• Report Number: 1216677-2017-00048
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician Assistant
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: LP-10-120
• Device Catalogue Number: LP-10-120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 07/06/2017 Patient Sequence Number: 1